Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training

NCT ID: NCT02099357

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to determine the effects of creatine monohydrate or vitamin D supplementation on strength gains following a traditional resistance training program for adults with spinal cord injury.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Creatine

Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks.

Group Type EXPERIMENTAL

Creatine

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with 3g of monohydrate creatine during 8 weeks

Vitamin D

Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D supplementation with 25000 IU each two weeks during eight weeks

Interventions

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Creatine

Daily supplementation with 3g of monohydrate creatine during 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Vitamin D supplementation with 25000 IU each two weeks during eight weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Spinal cord injury
* Minimum time since injury: 3 months

Exclusion Criteria

* Participation in resistance training programmes in the previous 6 months
* Creatine or vitamin D supplementation in the previous 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Samuel Amorim

Bsc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vitor H Teixeira, PhD

Role: STUDY_DIRECTOR

Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto

Rui Corredeira, PhD

Role: STUDY_CHAIR

Faculdade de Desporto, Universidade do Porto

Samuel Amorim, Bsc

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Desporto, Universidade do Porto

Locations

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Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais

Cantanhede, Coimbra District, Portugal

Site Status

Centro de Reabilitação do Norte

Vila Nova de Gaia, Porto District, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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FADEUPAFA20132015

Identifier Type: -

Identifier Source: org_study_id

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